Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Evaluate the effects of CTAC on ventilation/perfusion ratios during a moderate to severe ARDS
研究概览
简要总结
A Prospective, multicenter, randomized (two arms, parallel groups); double-blind, placebo-controlled in order to assess the ability of preoperative levosimendan to prevent post-operative low cardiac output in high-risk patients referred to cardiac surgery for correcting functional tricuspid regurgitation. The primary end point is a composite element that includes peri-operative mortality and low cardiac output syndrome at day-90: 1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for circulatory mechanical assist devices in the postoperative period, 3) or the need for renal replacement therapy at any time during intensive care unit stay. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point.The secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension.
详细描述
Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid are randomized in 2 arms, the levosimendan group or to the placebo group.
In the experimental group, levosimendan is administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.
In the comparator group, Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin <48H before anesthetic induction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation [effective regurgitant orifice (ERO)>20mm², or systolic hepatic vein flow blunting or reversal]
- •Written signed informed consent
- •Affiliation to the French health care system (Sécurité Sociale)
排除标准
- •Age < 18 years
- •Severe organic renal dysfunction defined by creatinine clearance <30mL/min
- •Recent endocarditis (<3 months)
- •Recent myocardial infarction (<3 months)
- •Tricuspid valve perforation or prolapse
- •Cardiogenic shock requiring dobutamine support or cardiac assistance
- •Severe liver injury (CHILD C)
- •Left ventricular obstruction
- •Allergy to levosimedan
- •Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
- •Pregnant or breastfeeding women
- •Females of childbearing potential without effective method of birth control
- •Patient on AME (state medical aid) unless exemption from affiliation
- •Hypotension with SBP<90mmHg
- •Severe tachycardia
- •History of torsade de pointe
研究组 & 干预措施
LEVOSIMEDAN
Levosimendan administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin 24H to 48H before anesthetic induction.
干预措施: Levosimendan (Drug)
PLACEBO
Placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. The infusion will begin <48H before anesthetic induction.
干预措施: PLACEBO (Drug)
结局指标
主要结局
Evaluate the effects of CTAC on ventilation/perfusion ratios during a moderate to severe ARDS
时间窗: day 90
The primary end point is a composite element that includes peri-operative mortality and low cardiac output syndrome at day-90: 1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for circulatory mechanical assist devices in the postoperative period, 3) or the need for renal replacement therapy at any time during intensive care unit stay. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point.
次要结局
- incidence of Refractory Hypotension (Drug safety)(day 90)
- Number of catecholamine infusion(during 90 days)
- Number of circulatory mechanical assist devices(during 90 days)
- Number of renal replacement therapy(during 90 days)